FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO AVANT 9600 PULSE OXIMETER
K Number: K040589
·
Decision Jun 3, 2004
Classifications
1
FEI Numbers
403
Registration Numbers
403
Same Product Code
711
Applicant Total
44
Review Days
87
Basic Information
- Device Name
- MODIFICATION TO AVANT 9600 PULSE OXIMETER
- K Number
- K040589
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.2700
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- NONIN MEDICAL, INC.
- Date Received
- March 8, 2004
- Decision Date
- June 3, 2004
- Product Code
- DQA
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DQA | Oximeter | FDA class 2 | Cardiovascular |
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Other Clearances by NONIN MEDICAL, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K160231 | Model X-100C CO-Met Oximetry System | Dec 23, 2016 | Substantially Equivalent |
| K160865 | Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series: 6100CA, 6100CP, 6100CI, 6100CN), Model 6101C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6101C Series: 6101CA, 6101CP, 6101CI, 6101CN), Model 6102C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6102C Series: 6102CA, 6102CP, 6102CI, 6102CN), Model 8100AA/8100AP Reusable, Finger Clip Pulse Oximeter Sensor, Model 8101AA/8101AP Reusable, Finger Clip Pulse Oximeter Senso | Aug 5, 2016 | Substantially Equivalent |
| K140785 | PULSE OXIMETER | Jul 7, 2014 | Substantially Equivalent |
| K132402 | SENSMART MODEL X-100 UNIVERAL OXIMETRY SYSTEM | Feb 21, 2014 | Substantially Equivalent |
| K131021 | PULSE OXIMETER | Sep 11, 2013 | Substantially Equivalent |
| K113215 | MODEL 7600 REGIONAL OXIMETER SYSTEM WITH EQUANOX TECHNOLOGY | May 14, 2012 | Substantially Equivalent |
| K112843 | PULSE OXIMETER | Apr 19, 2012 | Substantially Equivalent |
| K102350 | PULSE OXIMETER | Dec 22, 2010 | Substantially Equivalent |
| K102715 | REGIONAL OXIMETER | Dec 17, 2010 | Substantially Equivalent |
| K093853 | SINGLE-PATIENT USE DISPOSABLE SENSOR SERIES | Jun 4, 2010 | Substantially Equivalent |